Indian generic drugmaker Aurobindo Pharma officially launched its CRAMS unit AuroSource last week, also unveiling plans for an R&D facility in Pashamylaram near Hyderabad, India.
German contract manufacturing organisation (CMO) Excella will provide pneumatic dry granulation (PDG) tablet making services through a new partnership with Finnish specialty pharmaceutical firm Atacama Labs.
South Africa-based Aspen Pharma is to sell its Brazilian oral solid dosage form manufacturing facility to Strides Arcolab after posting a 15 per cent drop in revenues from Latin America.
A significant share of contract API maker ScinoPharm Taiwan is set to change hands after Watson Pharmaceuticals decided to sell its stake to Uni-President Enterprises Corporation.
US FDA clearance for Italian antibiotics production facility is important for global growth says German contract development and manufacturing organisation (CDMO) Haupt Pharma.
iBio has agreed in principle to license its iBioLaunch platform, which uses Nicotiana to produce therapeutics, to G-Con for the development and manufacture of plant-expressed influenza vaccines.
German pharmaceutical firm Merck KGaA says proposed Millipore acquisition will transform its chemicals unit and give it a more balanced business profile.
SAFC Pharma is preparing for the shift towards cell culture-based vaccines, while still supplying and growing in the traditional sector, to ensure it can grow in coming years, according to a company director.
Lek has opened a 430m² modified protein manufacturing facility in Slovenia to produce epoetin alfa drug substance for use in the biosimilars marketed by its parent company, Sandoz.
In the economic downturn biotechs have cut back on outsourcing to Asia and opted to use the US instead because they lack the resources to manage overseas relationships, according to a SOCMA representative.
Aesica is looking to acquire manufacturing assets in the US to expand its client base in the country and continue the growth it has maintained throughout the economic downturn.
Codexis’ enzymatic biocatalysis technology offers numerous processing and cost advantages for API and chemical intermediate manufacture says Dishman CRAMS unit president Nick Green.
There are signs that 2010 will be a better year for the fine and custom chemistry industry but companies at Informex remained cautious and are planning accordingly.
The Chinese API sector shrank last year after a number of high profile quality problems hit demand from Western markets, according to new analysis by outsourcing consultant JZ Med.
Contract API maker Ampac Fine chemicals (AFC) has had a busy 24-hours, entering the Japanese market through a deal with Inabata and forging an alliance with Codexis on biocatalyst technology.
US group Aptuit has bolstered its chemistry offering with a new solid state chemistry screen that it says will enable better decisions during drug formulation development and process scale-up.
The impact of the economic downturn is still being felt but SAFC remains "cautiously optimistic" about 2010, believing its close relationships with clients and investment in key emerging markets will generate business.
Revenues fell 3 per cent in 2009 at SAFC but pharmaceutical sector demand for vaccine manufacturing products helped firm finish year with six months of growth.
Cambrex reported a dip in revenues in 2009, citing the timing of orders throughout the year, and warned that smaller clients’ funding difficulties and pricing pressures will continue in 2010.
US CDMO Avrio Biopharmaceuticals’ new aseptic fill-and-finish facility in Irvine, California has been approved for the manufacture of biologics by state drug regulators.
The US FDA says its new screening system will expedite the importation of genuine drugs and help inspectors focus their efforts on “high risk” products.
Almost half of antimalarials in Senegal are substandard, according to a USP study which will be used by local regulators to focus efforts on high-risk products, brands and geographies.
The EFCG has welcomed the addition of excipient GMP requirements to the draft amendments of the EU falsified medicines directive but warned that deeper analysis is needed to establish which products warrant further regulation.
ISCO’s stem cell manufacturing facility has passed final building inspection, enabling it to implement the processes and cGMP standards needed to produce clinical-grade products.
Full-year income at the Lonza was hit by falling demand for life science ingredients and custom manufacturing services and only modest gains for its bioscience unit.
Environmental certification of production facilities should be introduced to GMP legislation and sustainability risk assessments linked to marketing authorisations, according to a MPA report.
Merck KGaA has begun work on a new inorganic salts plant in Darmstadt, Germany, citing growing demand as the main motivation for the €30m ($42m) investment.
Indian drugmaker Lupin can start seeking US approval for new drugs made at its API plant in Mandideep, Bhopal after resolving the cGMP deficiencies that earned the facility a US FDA warning last year.
AMRI’s plant in Rensselaer, New York gained SafeBridge potent compound certification this week after an effort that spokesperson Andrea Schulz said istestament to the firm's "willingness to go the extra mile”.
Lonza will shut down its API plant in Riverside, Pennsylvania, US by the end of the year as part of a plan to cut costs and shift small-molecule production to Asia.
Novavax has completed cGMP scale up of its RSV-F vaccine candidate, with the material being used in preclinical studies, and amended the terms of the H1N1 collaboration with Xcellerex.
GSK says it will start making its BPH drug Avodart (dutasteride) at its facility in Poznan, Poland when it completes a PLN70m (€17m) capacity upgrade in January next year.
Vaccines could be produced in less than 10 weeks from first isolation of the RNA sequence by using insect cell derived influenza VLPs, according to research which has implications for H1N1 and H5N1.
Ownership of FrieslandCampina Domo’s pharmaceutical lactose business will be transferred to DMV-Fonterra Excipients, the 50/50 JV set up by Domo owner Royal FrieslandCampina and partner Fonterra.
MedImmune has recalled unused doses of its intranasal H1N1 vaccine FluMist in the US after checks revealed that some had fallen below the minimum potency threshold in the two months since they were shipped.
The Indian pharmaceutical market was worth $10.8bn (€7.5bn) this year and will more than double in value by 2014 according to a new industry report by Cygnus Business Consulting & Research.
Geron says the USPTO appeals board granted a request to declare “interference” between a patent application owned by the firm and one issued to Novocell in March.
US formulation services provider Bend Research says a new safety file for the bioavailability enhancing drug excipient, HPMCAS, can now be referenced by its clients in FDA filings.
